title: Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management.
abstract: OBJECTIVE
  To describe real-life practice and person-centred outcomes in the treatment of poststroke upper limb spasticity with botulinum toxin A (BoNT-A).
  
  
  METHODS
  Observational, prospective study.
  
  
  METHODS
  84 secondary care centres in 22 countries.
  
  
  METHODS
  456 adults (≥18 years) with poststroke upper limb spasticity treated with one cycle of BoNT-A.
  Muscle selection, BoNT-A preparation, injection technique and timing of follow-up were conducted according to routine practice for each centre.
  
  
  METHODS
  achievement of the patient's primary goal for treatment using goal-attainment scaling (GAS). Measurements of spasticity, standardised outcome measures and global benefits were also recorded.
  
  
  RESULTS
  The median number of injected muscles was 5 (range 1-15) and the most frequently injected muscles were the long finger flexors, followed by biceps and brachioradialis. The median (range) follow-up time was 14 (2.6 to 32.3) weeks. The common primary treatment goals were passive function (132 (28.9%)), active function (104 (22.8%)), pain (61 (13.4%)), impairment (105 (23%)), involuntary movement (41 (9%)) and mobility (10 (2.2%)). Overall, 363 (79.6%) (95% CI 75.6% to 83.2%) patients achieved (or overachieved) their primary goal and 355 (75.4%) (95% CI 71.2% to 79.2%) achieved their secondary goal. Mean (SD) change from baseline in GAS T-scores was 17.6 (11.0) (95% CI 16.4 to 18.8; p<0.001). GAS T-scores were strongly correlated with global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001).
  
  
  CONCLUSIONS
  BoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper-limb spasticity following stroke. The study confirms the feasibility of a common international data set to collect systematic prospective data, and of using GAS to capture person-centred outcomes relating to passive and active functions and to pain.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01020500.
authors.affiliation: Department of Palliative Care, Policy and Rehabilitation, School of Medicine, King’s College London, London, UK. lynne.turner-stokes@dial.pipex.com
authors.forename: Lynne
authors.initials: L
authors.lastname: Turner-Stokes
authors.affiliation: Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria.
authors.forename: Klemens
authors.initials: K
authors.lastname: Fheodoroff
authors.affiliation: Centro de Medicina de Reabilitaçãode Alcoitão, Serviço de Reabilitação de adultos 3, Estoril, Portugal.
authors.forename: Jorge
authors.initials: J
authors.lastname: Jacinto
authors.affiliation: 4Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Maisonobe
keywords: botulinum toxin A; goal attainment scaling; post-stroke spasticity; stroke rehabilitation